The purpose of this study is to determine whether lenalidomide can stop the growth of leukemia stem cells and can be used to prevent the return of leukemia cells after a transplant.
The purpose of this study is determine whether lenalidomide can directly inhibit leukemic stem cells in vivo and can be used to prevent the relapse of leukemia stem cells after transplant. A concern with any post transplant intervention is the possibility of multiple drug interactions, potential for graft versus host disease exacerbation and/or induction of cytopenia. Therefore, the smallest doses of lenalidomide (5 mg) that has been used in this setting will be utilized as dose level 1. Starting six months post-transplant, patients will begin on a daily dose of lenalidomide. Dependent on the cohort, patients will receive 5 to 20 mg of lenalidomide post transplant. The maximum tolerated dose (MTD) will be determined by the incidence of grade III-IV toxicities of all organs and grade II-IV GVHD. Duration of treatment is six months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle.
University of California Davis
Sacramento, California, United States
Maximum-tolerated dose as assessed by NCI CTCAE, Version 4.0 and Graft versus Host Disease Staging
All patients will be followed closely and evaluated for toxicity. For grade III-IV non hematological toxicity or grade IV hematological toxicity associated with lenalidomide will be held until the toxicity resolves and then will be started at a lower dose; Patients who develop grade II to IV GVHD on study will stop lenalidomide
Time frame: 4 week cycle; the expected time frame is 24 weeks (or 6 cycles)
Disease relapse
Percentage of patients with relapse from all the patients who received the transplant.
Time frame: One year
Disease-free survival
Percentage of patients who are alive and remain in remission at one year after infusion of stem cells
Time frame: One year
Incidence of Graft versus Host disease
The percentage of pathologically confirmed cases of acute and/or chronic Graft versus Host disease at one year post transplant
Time frame: One year
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